Food Contact & Food Additives_Laura Wang

China Food Additives regulatory
developments
REACH24H CONSULTING GROUP
LAURA WANG

REACH24H CONSULTING GROUP LAURA WANG
Content 1. An introduction of China Food Additives Regulation System
2. The updates of China Food Additives Regulation
• Updates in Food Safety Law
• Updates in GB 2760-2014
1. Some practical tips

• Leading compliance solution provider in China and AP
region on
• Chemicals
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• Professional turnkey service of food importation to China
• Registration services on new food additives, food contact
materials and food raw materials
• Tailor-made consultation service
• Regulation information platform of China & AP Region
• Practical tools such as regulatory database, inventory tool
box, etc.
• Webinars of development of regulations

Regulation system in China
Which direction
Basic Law
Food Safety Law
How to do
Measures
• Administrative Measures on New
Varieties of Food Additives;
• Provisions on Application and
Acceptance of New Varieties of
Food Additives;
• Provisions on Supervision and
Administration of Production of
Food Additives;
• General Rules on Examination for
Food Additive Production
License
• etc.
What’s the details
Standards
• GB 2760 Standard for Uses of
Food Additives;
• GB 31624 Standard for Beta –
carotene;
• GB 8273 D-isoascorbate;
• GB 4578 Saccharin sodium;
• GB 3861 Vanillin;
• GB 1976 Sodium alginate;
• GB 22216 Hydrogen peroxide
• GB 1976 Sodium alginate
• 200+ GB standards

Definition and scope of Food Additives
US EU China
Direct food additives ● ● ●
Flavor ● - ●
Enzyme ● - ●
Food fortifiers ● - ●
Food processing aid ● - ●
Food contact additives ● - -
Food ingredients ● - -

How food additives are managed in China
Assessing Safety
NHFPC
• Draft and publish
relevant standards;
• Assess safety of food
additives
• Approve new food
additives
Manufacture/Importation
CFDA, AQSIQ
• Manage the manufacturing of
food additives
• Monitor the circulation of food
additives in the market
• AQSIQ is in charge of the
importation of food additives
and food additives used in the
food
Monitoring & Inspection
Local FDA
• Monitor and inspect time to time
about the trade and
manufacturing of food additives
• Publish the results to the public

FoodAdditivesstandards
Application
standard
Product
standards
Labelling
standards
Manufacturing
Practice
GB29924 General rules on food additives
labelling
Manufacturing regulations of food additives
200+ product standards
GB26687 General rules of Compound Food
Additives
GB25594 Enzyme used in food industry
GB30616 Food flavor
GB29983 General rules on Food flavor
GB29987 Chewing gum bases and their
ingredients
GB2760 Standard for Uses of Food Additives
GB14880 Standard for Nutritional Fortifiers

Updates in China Food
Additives Regulations
1. Updates in Food Safety Law
2. Updates in GB 2760 - 2014

Updates in Food Safety Law 2015
2 National standards
3 Production
Food Safety Risk Surveillance and
Assessment
1
4 Imported food
5 Legal liabilities

3 Production
Assessment
1
4 Imported food
5 Legal liabilities
I Article 21 Food safety risk assessment results shall be the
scientific basis for developing and modifying food safety
standards, as well as food safety regulatory work.
In case the food safety risk assessment conclusion shows a
food, a food additive, or a food related product is unsafe,
CFDA and AQSIQ shall immediately inform consumers to stop
consumption or usage of the product, and take actions to
terminate product and trading of the food, food additive
and food-related products; if necessary, NHFPC shall
immediately formulate or modify the relevant food safety
national standards in conjunction with CFDA.
“
”Chapter 2 Food Safety Risk Surveillance and
Assessment

3 Production
Assessment
1
4 Imported food
5 Legal liabilities
Article 26 Food safety standards shall include the following
standards
1) Limits of pathogenic microorganisms, pesticide residues,
veterinary drug residues, heavy metals, biotoxins,
contaminants, and other substances hazardous to human
health in food, food additives and food-related products;
2) Varieties, scope of application, and dose of food
additive use;
3) …..
“
” Chapter 3 Food Safety Standards

3 Production
Assessment
1
4 Imported food
5 Legal liabilities
Article 39 The State adopts a licensing system for the production of food
additives. Food additives production shall have venue,
equipment/facilities, professionals and management system that match
the produced food additive variety, the producer shall, in accordance
with the procedure of Article 35.2 of this law, obtain the food additive
producing license. The production of food additives should be in
accordance with laws, regulations and food safety national standards.
“
”
Article 59 Food additives manufacturers shall establish delivery inspection
record system to check the compliance certificates and safety status of
outgoing products. They shall truly record information such as name,
specification, quantity, production date or batch number, shelf life,
compliance certificate number, date of selling, as well as name, address
and contact information of the purchaser. The records and documents
shall be kept in compliance with provisions in Article 50.2 of the Law.
Chapter 4 Food Production and Trading

3 Production
Assessment
1
4 Imported food
5 Legal liabilities
“
”Chapter 6 Food Import and Export
Article 92 Imported foods, food additives and food-related products
shall comply with China’s national food safety standards. Imported
foods and food additives shall pass inspection by the exit-entry
inspection and quarantine agencies (CIQ) pursuant to laws and
administrative regulations.
Imported foods and food additives shall be accompanied by
inspection certificates, as required by AQSIQ.

3 Production
Assessment
1
4 Imported food
5 Legal liabilities
“
” Chapter 9 Legal liabilities
Article 124 …The producer or trader is also subject to a fine between RMB
50,000 to 100,000 if the total value of the commodity is less than RMB
10,000, or a fine between 10 and 20 times if the total value of the
commodity exceeds RMB 10,000; for severe violation of the law, the
business license of food producers and traders will be revoked:
1) Producing or trading food and food additives which exceed food
safety
standard limits in relation to pathogenic microorganisms, pesticide
residues, vet drugs residues, biotoxins, heavy metals, and other substances
hazardous to human health;
2) Producing or trading foods and food additives with food materials and
food additives that have passed the shelf life;
3) Producing or trading food involved using food additives beyond
allowed scope or excessively use of food additives;
4) Producing or trading foods and food additives which are rotten or
spoiled, have rancid fat, grows with molds or insects, are dirty or
contaminated, contain foreign matter, adulterated with alien substances,
or display abnormal sensory indication;
…
8) Using new food materials to produce food, or producing new varieties
of food additives without a safety assessment;
…

Updates in GB 2760-2014
Standard for Uses of Food Additives
1 3
Consolidation of the
public notice from
NHFPC
2
Removes the part of
nutritive fortify and
chewing gum bases
and their ingredients,
which will be
regulated by
another specific
standard
Modify the carry-
over principle
4
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix D and
Modify the Appendix
F

1
Consolidation of the
public notice from
NHFPC
• Public notices are like the extension of GB 2760
• Adds the announcements that are published since the release of
GB2760 – 2011 that enables better search

• Food nutritive fortifier is no longer regulated as food additives but
regulated under GB 14880
• The chewing gum is no longer regulated by GB 2760, which will
be regulated by another specific standard. But it still belongs to
Food additives.
2
Removes the part of
nutritive fortify and
chewing gum bases
and their ingredients,
which will be
regulated by
another specific
standard

3
Modify the carry-
over principle
3.4.2 Anti-carry-over principle
On the condition that certain food ingredient is served as a raw
material of a specific final product, the food additive which is
applied to the aforementioned specific final product are approved
to be added in the food ingredient, while at the same time the level
of the food additive in the final product shall comply with the
requirements in this standard. It shall be clearly indicated on the
label of the aforementioned food ingredient that it is used for the
production of the aforementioned product.
“
”

• Modify 14 aluminum related food additives
• Modify usage standards of 17 food additives, i.e. Aspartame
• Delete 34 provisions of 28 additives that are not technical
unnecessary
• Some food additives and their provisions for use are deleted,
including octylphenol polyoxyethylene, starch aluminum
octenylsuccinate, and β-naphthol, etc.
4 Appendix A provisions for use of food additives
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix and
Modify the Appendix
F Food classification
system

• Some food essences are deleted as they are listed in food spices
and classified as food seasonings
• “ Tea, coffee” is added in Appendix B.1 (List of foods not allowed
to be added with flavorings and essences)
• Add the notes regarding “The permitted food use synthetic
flavoring substances” in Appendix B.3
4 Appendix B provisions for use of food flavorings
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix and
Modify the Appendix
system

• Hydrogen peroxide is included in Appendix C.1 (List of
processing aids that can be used during the course of various
foods processing without residual limits (excluding enzyme
preparations))
• Methanol, palladium, polyglycerol ester of polylinoleic acid and
their provisions for use are removed from Appendix C.2 (List of
processing aids that need stipulated functions and applications
scopes (excluding enzyme preparations)).
4 Appendix C provisions for use of processing aids for food
industry
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix and
Modify the Appendix
system

• Delete the regulations of chewing gum
• It will be regulated by specific standard (GB29987)
4 Appendix D list of chewing gum bases and their ingredients
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix and
Modify the Appendix
system

• Parts of food names or classifications are modified
• The classification of food for special dietary uses is deleted
• Food additives in this classification are regulated by GB
29922-2013 Formula foods for special medical uses
• Food additives in this classification are regulated by
products standards
4 Appendix F Food classification system
Modify the Appendix
A , Appendix B,
Appendix C; Delete
the Appendix and
Modify the Appendix
system

Contents
Num.
Appendix A
(Food additives)
Appendix B
(Food flavoring)
Appendix C
(Processing aid
Appendix D
(Chewing gum)
Summary
GB 2760-2011 332 1853 162 55 2314
GB 2760-2014 336 1866 169 0 2333

Summary of the Updates in China Food
Additives Regulations
2 Adopts part of
overseas/international way
3 Emphasize the
technical necessity of
food additives
Emphasize the importance
of food additives
1

Some practical tips 1. A working flow for imported food traders/manufacturers
2. A working flow for imported food additives
3. A very brief introduction of new food additives registration

Ingredients
review
Food raw materials
review
Food additives
review
Whether the food
additives are
included in GB 2760
- 2014
Check the scope
and function of the
food additives
Check the
maximum limits
Label review – GB
7718 - 2011
A working flow for imported food
traders/manufacturers

Ingredients
review
Food raw materials
review
Food additives
review
Whether the food
additives are
included in GB 2760
- 2014
Check the scope
and function of the
food additives
Check the
maximum limits
Label review – GB
7718 - 2011
A working flow for imported food
additives
Import to China
Register new food
additives/Extend
the scope (or
amount) of use

Register new food additives
or extend the scope/amount of use
1 3
Shall at least used in
other regions of the
world, better if in
US/EU
2
Prove safety and
technical necessity
Timeline lasts at least
12 months;
Cost depends on
the availability of
data and the usage
of the additives in
other regions

Contact
for any further questions
Email: laura.wang@cn.reach24h.com
Laura Wang
REACH24H CONSULTING GROUP
Tel: +86 571 8700 7519

Food Contact & Food Additives_Laura Wang

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